Alinity m STI Assay— 510(k) K202977

Substantially Equivalent

Abbott Molecular, Inc.

FDA 510(k) clearance K202977 for Alinity m STI Assay, Substantially Equivalent on 2022-04-29. Applicant: Abbott Molecular, Inc..

Clearance details

Applicant: Abbott Molecular, Inc.
Product code: Code QEP
Advisory panel: Microbiology
Date received: 2020-09-30
Decision date: 2022-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

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